What side effects are associated with this type of intervention?

Common treatments for solid tumors, particularly targeted therapies like JDQ443, often include tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors. TKIs can cause side effects such as diarrhea, fatigue, hypertension, and skin rashes. Immune checkpoint inhibitors, such as PD-1/PD-L1 inhibitors, may lead to immune-related adverse events including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Both types of therapies can also result in general side effects like fatigue and gastrointestinal disturbances.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of solid tumors. Notably, sotorasib (Lumakras) and adagrasib (Krazati) have been approved for the treatment of non-small cell lung cancer (NSCLC) with the KRAS G12C mutation. These drugs specifically inhibit the KRAS G12C protein, similar to the investigational drug JDQ443. Additionally, other targeted therapies like pembrolizumab (Keytruda) and nivolumab (Opdivo) have been approved for various solid tumors, focusing on immune checkpoint inhibition rather than direct mutation targeting.

What other types of research exist?

Promising alternatives to JDQ443 for solid tumors include: 1) Pembrolizumab (an immune checkpoint inhibitor) combined with chemotherapy, as shown in the KEYNOTE trials for various cancers. 2) Atezolizumab (another immune checkpoint inhibitor) combined with bevacizumab, particularly for renal cell carcinoma and other solid tumors. 3) Cabozantinib, a tyrosine kinase inhibitor, which has shown efficacy in combination with immunotherapies like nivolumab. 4) Nivolumab and ipilimumab combination therapy, which has been effective in several solid tumors including renal cell carcinoma and sarcomas.

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JDQ443 for Cancer (KontRASt-01 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care or are intolerant or ineligible to approved therapies

ECOG Performance Status of 0 or 1

Must not have

A medical condition that results in increased photosensitivity

Clinically significant cardiac disease or risk factors at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, JDQ443, alone and with two other drugs, in patients with advanced solid tumors. It aims to find the safest dose and see if the combination can effectively reduce tumors.

Who is the study for?

This trial is for adults with advanced solid tumors that have a specific mutation called KRAS G12C. They should have tried standard treatments or be unable to take them, and may have had previous KRAS G12C inhibitor treatment. Participants need at least one tumor that can be measured and must be fairly active and able to care for themselves.

What is being tested?

The study is testing the safety and effectiveness of JDQ443 alone, and in combination with TNO155 or tislelizumab, in patients with certain advanced cancers. It's an early-phase trial where doses are increased until they find the highest dose people can tolerate without severe side effects.

What are the potential side effects?

Possible side effects include reactions related to the immune system since tislelizumab boosts immune activity against cancer cells. Other common drug-related issues might involve skin sensitivity to light, fatigue, digestive problems, changes in blood tests or heart complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have advanced cancer with a KRAS G12C mutation and can't take standard treatments.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am highly sensitive to sunlight due to a medical condition.

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I have heart problems or risk factors for heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Escalation: Dose intensity by treatment

Dose Escalation: Frequency of dose interruptions and reductions, by treatment

Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

+7 more

Secondary study objectives

Dose Escalation and Expansion: Antidrug antibody (ADA) incidence by treatment

Dose Escalation and Expansion: Best Overall Response (BOR) per RECIST v1.1

Dose Escalation and Expansion: Disease Control Rate (DCR) per RECIST v1.1

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm DExperimental Treatment3 Interventions

JDQ443 in combination with TNO155 and tislelizumab

Group II: Arm CExperimental Treatment2 Interventions

JDQ443 in combination with tislelizumab

Group III: Arm BExperimental Treatment2 Interventions

JDQ443 in combination with TNO155

Group IV: Arm AExperimental Treatment1 Intervention

JDQ443

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Targeted therapies for solid tumors, such as those being studied in the JDQ443 trial for KRAS G12C mutations, work by specifically inhibiting proteins or pathways critical for cancer cell growth and survival. These treatments, including EGFR, ALK, and BRAF inhibitors, focus on genetic mutations unique to the tumor, allowing for a more personalized and effective approach. This precision reduces damage to normal cells and minimizes side effects, offering solid tumor patients a better quality of life and potentially improved treatment outcomes.

Potential Anticancer Mechanisms of a Novel EGFR/DNA-Targeting Combi-Molecule (JDF12) against DU145 Prostate Cancer Cells: An iTRAQ-Based Proteomic Analysis.